Effects of 5-Aminolevulinic Acid on Glucose Metabolism | NCT01610778

Studies
Effects of 5-Aminolevulinic Acid on Glucose Metabolism

NCT01610778

Sponsor

Hiroshima University

Status

Completed

Last Update Posted

Dec 19, 2013Estimated

Enrollment

35Estimated

Phase

Not Applicable

Conditions

Type 2 Diabetes on Medication

Interventions

Placebo
5-aminolevulinic acid phosphate

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

May 31, 2012

First Submission Date that Met QC Criteria

May 31, 2012

First Posted Date

Jun 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2013

Last Update Posted Date

Dec 19, 2013Estimated

Name	Class
SBI Pharmaceuticals Co, Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is designed to evaluate efficacy of 5-aminolevulinic acid in subjects with type 2 diabetes on medication.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Dietary Supplement: Placebo
Supplement	Experimental		Dietary Supplement: 5-aminolevulinic acid phosphate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement		Placebo
5-aminolevulinic acid phosphate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fasting glucose level		Every 4 weeks (Overall 36 weeks)
HbA1c level		Every 4 weeks (Overall 36 weeks)
Glycoalbumin level		Every 4 weeks (Overall 36 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Fasting insulin level		Every 4 weeks (Overall 36 weeks)
1,5-AG level		Every 4 weeks (Overall 36 weeks)
Serum C-peptide level

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetic patients on medication
HbA1c ≤ 9.0% (as JDS values, which is equivalent to HbA1c ≤ 9.4% as NGSP values)
On stable treatment of diabetes for at least the last 3 months
With permission to attend the clinical trial from the primary doctor

Exclusion Criteria:

On insulin therapy
BMI ≤ 18 kg/m2 or ≥ 30 kg/m2
History of porphyria, hemochromatosis, or viral hepatitis
Pregnant or nursing a child
Heart disease
Renal or hepatic dysfunction
Participation in any clinical trial within 90 days of the commencement of the trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hiroshima University		Hiroshima		7320814	Japan